§9.3 Health Claims

• Jurisdiction: United States
• Publication year: 2022

§9.3 Health Claims

Under the Nutrition Labeling and Education Act of 1990 (NLEA),²⁰ a claim was permitted for foods that ". . . characterizes the relationship of any nutrient . . . to a disease or health-related condition . . .," thus permitting "health" claims for foods.²¹

Health claims were allowed based on a regulation authorizing the use of the claims with the particular food. The authorizing regulation was put forward by the Secretary after determining there was "significant scientific agreement" among experts that the claim was supported by publicly available scientific evidence.²² This review by the Secretary was a de facto approval process for health claims applied to foods.²³

The provisions of the NLEA were stayed by the Dietary Supplement Act of 1992²⁴ until December 1993. Prior to the enactment of NLEA, H.R. 1709 was introduced to address the labeling of dietary supplements.²⁵ Senate bill 784 was put forward in April 1993, and was eventually enacted as the Dietary Supplement and Health Education Act of 1994.²⁶ In passage of DSHEA, it was stated that NLEA would remain in effect for dietary supplements.²⁷

§9.3.1 Pearson v. Shalala

Up through and continuing past DSHEA, the FDA appeared to be reluctant to approve health claims for dietary supplements, approving only two until 1999.²⁸ The Food and Drug Administration Modernization Act of 1997²⁹ included provisions to allow the use of unauthorized health claims for food if a scientific body of the U.S. government has published an authoritative statement about the relationship between a nutrient and a disease or health-related condition.³⁰

Regardless of the Food and Drug Administration Modernization Act, the FDA continue to deny health claims for foods based on stringent standards. That method of regulating health claims was challenged in Pearson v. Shalala, 164 F.3d 650 (1999) after the FDA denied filed health claims.³¹ In ordering the FDA to reconsider the petitioner's health claims, the court held the FDA's lack of satisfactory explanation for the rejection of the health claims as a violation of the Administrative Procedure Act.³² A satisfactory explanation includes a definition provided for the phrase "significant scientific agreement." "It simply will not do for a government agency to declare—without explanation—that a proposed course of private action is not approved."³³

§9.3.2 FDA Current Health Claim Regulation

The FDA's current method of analyzing health claims may be gauged from a current letter sent to a petitioner in reply to a health claim filing.³⁴ The filed claim was as follows: "Daily consumption of 40 ounces of typical green tea containing 710 µg/ml of natural (-)-epigallocatechin gallate (EGCG) may...